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Clinical Trials in China / NCT07024420
Recruiting Not applicable

Sigh Ventilation in Cardiac Surgery

NCT07024420 · tracked via the Priya Life Science China tracker
Sponsor
Zhongda Hospital
Phase
Not applicable
Started
2025-10-09
Last updated
2025-11-18

Condition(s) studied

Postoperative Pulmonary Complications (PPCs)Cardiac Surgery in Adult Patient

Investigational drug(s) / intervention(s)

Sigh BreathsLow Tidal VolumeModerate PEEP

Sigh Breaths: Sigh breaths were added by elevating PEEP, targeting a plateau pressure of 35 cmH2O (or 40 cmH2O for patients with a Body Mass Index \> 35 kg/m2). These sigh breaths were administered once every 6 minutes at predefined stages in the perioperative period from the time of anesthesia intubation until endotracheal extubation, postoperative day 7, or death, whichever occurred first, but not during transport. Each sigh consisted of the minimum number of respiratory cycles aimed to achieve a total duration of at least 5 seconds, based on the respiratory cycle duration preset on the ventilator.

Low Tidal Volume: 6-8ml/kg predicted body weight

Moderate PEEP: PEEP set according to ARDSnet low PEEP- fraction of inspired oxygen table, FiO2 was set as the lowest fraction targeted to maintain SpO2 ≥ 96%

Study summary

The purpose of this trial is to investigate whether sigh ventilation strategy, combining sigh breaths, low tidal volume, and moderate PEEP levels, protects against major pulmonary complications within the first 7 postoperative days after cardiac surgery, as compared with conventional ventilation strategy with low tidal volume, and moderate PEEP levels.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 18 years of age or older; * Elective cardiac surgery with cardiopulmonary bypass, aortic clamp and cardioplegia; * Written informed consent is obtained from patients and/or their legal representatives. Exclusion Criteria: * Emergence surgery; * Left ventricular assist device implantation; * Planned thoracotomy with one lung ventilation; * Undergo concurrent surgical procedures outside cardiology; * Neuromuscular illness; * Mechanical ventilation within the last 2 weeks before surgery, include CPAP and NIV; * Preoperative shock; * Preoperative Hypoxemia (PaO2\<60mmHg OR SpO2\<90% on ambient air); * Preoperative left ventricular ejection fraction \< 40%; * Systolic pulmonary artery pressure \> 50 mmHg.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongda Hospital, Southeast University Nanjing Jiangsu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07024420 on ClinicalTrials.gov ↗ ← All trials in China